Determination of Selective Bone Turnover Markers and Their Association With Treatment Efficacy in Primary Postmenopausal Osteoporotic Women: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Bone Turnover Markers (BTMs)
研究概览
简要总结
This study investigates the use of blood tests known as Bone Turnover Markers (BTMs) to quickly monitor the effectiveness of osteoporosis treatment in postmenopausal women. Osteoporosis, which weakens bones and increases fracture risk, is typically monitored using a DEXA scan to measure bone density (BMD), but this method changes slowly. BTMs may show a response to medication within just 3 to 6 months. In this randomized controlled trial, 40 postmenopausal women with osteoporosis will be assigned to receive either antiresorptive drugs (which slow bone loss) or anabolic drugs (which build new bone), along with calcium and vitamin D. The study will compare how these treatments affect BTMs and BMD over six months to determine if BTMs can serve as an early and reliable indicator of treatment success, which could be particularly useful in regions like Pakistan where access to repeated DEXA scans is limited.
详细描述
A randomized controlled trial will be conducted to evaluate the association between selective BTM and the efficacy of different drug therapies in primary postmenopausal osteoporotic women. The study is motivated by the high prevalence of osteoporosis in this demographic in Pakistan and the limitations of the current gold standard, BMD measured by DEXA scan, which reflects changes in bone strength at a delayed rate. BTMs, being biochemical indicators of bone formation and resorption, offer a dynamic and rapid assessment of bone metabolic activity, potentially providing an early measure of treatment response within months rather than years. The trial will enroll 40 eligible women over 50, who will be randomly and blindly assigned to one of two treatment groups: one receiving antiresorptive drugs (such as Alendronate) and the other receiving anabolic drugs (Teriparatide), both supplemented with calcium and vitamin D for a six-month period. The primary outcomes include the comparative change in specific BTMs (BsALP, TRACP-5b, and Sclerostin) at three and six months, and the change in BMD at six months. Secondary outcomes will assess the correlation between BTM and BMD changes, as well as fracture incidence and quality of life. By analyzing these parameters, the study aims to generate valuable evidence for the utility of BTMs in guiding and monitoring osteoporosis treatment in a Pakistani clinical setting, potentially leading to more responsive and personalized patient management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The protocol states this will be a "double blinded study" where "the participant and researcher will be unaware of the interventions until the participants complete their 6 months of interventions. Only the research assistant will be aware of the interventions given."
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (at least one year since last menstrual cycle).
- •Age greater than 50 years.
- •Diagnosis of primary osteoporosis.
- •Currently not on any anti-osteoporosis medications.
- •Not taking Calcium or Vitamin D supplements.
- •Volunteer to participate and provide informed consent.
排除标准
- •Women with multiple vertebral fractures or severe lumbar degenerative changes.
- •Use of hormone/estrogen therapy, calcitonin, oral bisphosphonates, IV ibandronate, IV Zoledronic acid, denosumab, or teriparatide within the past 18 months.
- •Use of corticosteroids (short or long-term).
- •History of hyperthyroidism, hypothyroidism, liver disease, kidney disease, or tumors.
- •Presence of secondary causes of osteoporosis (e.g., eating disorders, celiac disease, diabetes, hematologic disorders).
研究组 & 干预措施
Antiresorptive Therapy Group
Participants will receive one of the following oral antiresorptive drugs for 6 months: Alendronate 70mg weekly, Ibandronate 150mg monthly, or Risedronate 150mg monthly. All participants will also receive Calcium and Vitamin D supplementation.
干预措施: Alendronate, Ibandronate; Risedronate (Drug)
Anabolic Therapy Group
Participants in this group will receive the anabolic drug Teriparatide 20 mcg, administered as a daily subcutaneous injection, for a duration of 6 months. In addition, all participants in this arm will receive daily Calcium and Vitamin D supplements.
干预措施: Teriparatide (Drug)
结局指标
主要结局
Change in Bone Turnover Markers (BTMs)
时间窗: Baseline, 3 months, and 6 months.
Mean change from baseline in the serum levels of specific bone turnover markers, including the bone formation marker Bone-Specific Alkaline Phosphatase (BsALP) and the bone resorption marker Tartrate-Resistant Acid Phosphatase 5b (TRACP-5b), and the osteocyte marker Sclerostin.
Change in Bone Mineral Density (BMD)
时间窗: Baseline and 6 months.
Mean change from baseline in Bone Mineral Density (BMD) T-score as measured by Dual-Energy X-ray Absorptiometry (DEXA) scans at the hip, spine, and femoral neck.
次要结局
- Incidence of New Fractures(Through study completion, an average of 6 months.)